# EPA SANITIZED

UNITED STATES ENVIRO NMENTALPROTECTION AGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF NEW CHEMICAL SUBSTANCES PENDINGDEVELOPMENT OF INFORMATION 

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Inthematterof: ) ) ) ) ) ) ) ) ) ) ) ) PremanufactureNoticeNumbers:



### [
. - . . - . ..... .. .. . . ] P-13-646,647,648,649,678, and 679

Consent Order and Determinations Supporting Consent Order11



### TABLE OF CONTENTS

Preamble I. Introduction II. Summary ofTerms ofthe Order III. Contents ofPMNs IV. EPA's Assessment ofExposure and Risk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health and Environmental Effects

onsent Order I. 

### Scope ofApplicability and Exemptions II. Terms ofManufacture, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Record-keeping IV. Requests for Pre-InspectionInformation V. SuccessorLiability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order Attachment A

- Definitions Attachment B -Notice ofTransferofConsent Order111 

### PREAMBLE I. INTRODUCTION Under the authority of§ 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e)), the Environmental ProtectionAgency ("EPA" or "the Agency") issues the attached Order, regarding six premanufacture notices ("PMNs"), P-13-646, 647, 648, 649, 678, and 679 submitted by 

### I ] ("the Company"). The Company submitted the PMNs to EPApursuantto § 5(a)(l) of TSCA and 40 CFRPart 720. Under § 15 ofTSCA, it is unlawful for any person to fail orrefuse to comply with any provision of§ 5 or any order issued under§ 5. Violators may be subject to various penalties and to both criminal and civil liabilitypursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substances subject to an Order issued under§ 5 ofTSCA, such as this one, are subject to the§ 12(b) export notice requirement.

II. SUMMARY OF TERMS OF THE ORDER The Consent Order for these PMN substances requires the Companyto: (a) submit to EPA certain toxicity and physical/ chemical and environmental fate testing relevant to the hazard and risk assessment ofthe fluorinated portion ofthe six current PMN substances governed by the attached Consent Order; (b) report annually and comply withthe impurity content ofall the [. j and impurities with carbon chain lengths greaterthan [, ]by analyzing representative samples; and ( c ) maintain certainrecords.IV Although a Consent Order for ContractManufacturer is not attached to extendthese requirements to an identified Contract Manufacturer, the Company may use a Contract Manufacturerto manufacture these substances inthe future. The Consent Order establishes the requirements for the Company ifa Contract Manufacturer manufactures the PMN substances. The Company must submit the Contract Manufacturer identity and other manufacturing process and exposure and release information concerning the Contract Manufacturer and thenthis Consent Order could be modified upon approval by EPA. The ContractManufacturer would be required to keep records ofquantities manufactured, but the Company must submit to EPA the required testing.

III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order): company identity, specific chemical identities, physical form, production volumes, processing, and use information, and other information Chemical Identities: Specific: P-13-646: [



### J;v P-13-647: [
j; P-13-648: [-
j; P-13-649: 

## l· ]; P-13-678: [: 

## 1and P-13-679: [- ]. Generic Name: P-13-646 and 648-- Fluoroalkyl acrylate copolymer modified withpolysiloxanes; P-13-647, 649, and 679-Fluoroalkyl acrylate copolymer; and P-13-678-Fluoroalkyl methacrylate copolymer Use: Specific: P-13-646-[ ]; P-13-647-[ 

## J; P-13-648-[ ]; P-13-649-1 ]; P-13-678-[' 

## 1; and P-13-679- ]. Generic use: P-13-646, 648-tile treatment; P-13-647,649-textile treatment; P-13-678-water and oil repellent for plastic and inorganic substrates; P-13-679-papertreatmentVl

Maximum 12-Month Production Volume: P-13-646-[: 

## l kgs; P-13-647-r ] kgs; P-13-648-[ ] kgs; P-13-649-l ]kgs; P-13-678-[ ] kgs; and P-13-679-[ ] kgs. Test Data Submitted with PMNs: P-13-647 and 649-Ames test.

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK The following are EPA's predictions regarding the probable toxicity, human exposure and environmental release ofthe PMN substances, based on the information currently available to the Agency. Human HealthEffects and Fate Summary: EPA has concerns for potential incineration or otherpotential degradation products, byproducts, unreacted material, and lowmolecular weight species ofthe PMN substances. EPA also has concerns that the PMNpolymeric substances themselves under some conditions ofuse-- particularly non-industrial, commercial, or consumeruse-- could cause lung effects, based on limited data on some 

## L Jcompounds. EPA has concerns for the potential degradation ofthese polymers and for the subsequent [: .]. The PMN substances degrade**to~~-** ·]. Based
oninformation submitted to EPA during the PMNreviewperiod, these substances have some [ 

## -l impurities. To further document the actual contamination and efforts to reduce impurity levels, the Company has agreed to limits in the starting materials and report the various fluorinated [ 

### Jimpurities and [ l periodically. [ ]has reported the [ ] impurities and [ 

### Jin compliance with previous Consent Orders. [

-- ··- --t] no longer makes the L 

### JproductsVll at the same facilities as the PMN substances. EPA strongly encourages the continued effort to maintain these low levels of

### l there are no longer any 

## l· 'l impurities and to make improvements until l] in these products. Perfluorinated products may be released to the environment from incomplete incineration ofthe PMN substances at lowtemperatures. Preliminary evidence suggests that under some other conditions, the PMN substances could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate orbiomagnify, and couldbe toxic ("PBT") to people, wild mammals, and birds based on data on analog chemicals, including PFOA. The potential 

### Jdegradants for these PMN substances include [ 

### •]. The analog PFOA is expected to persist for years in the environment. Biodegradation and photolysis tests ofanalogous substances indicate little orno biodegradation orphotolysis of perfluoroalkyl compounds. Bioaccumulationconcerns are based onthe measured presence ofcertain perfluoroalkyl compounds, including PFOA, in wildlife and inhumanblood samples. Toxicity studies
onPFOA indicate developmental, reproductive and systemic toxicity in various species. Cancer may also be ofconcern. These factors, taken together, raise concerns for potential adverse chronic effects in humans and wildlife. For additional information about PFOA, consult the EPAregulatory docket at EPA-HQ-OPPT-2003-0012. Additional information about PFOA and otherperfluorinated substances may also be found in theAdministrative Record for PFOS, PFOA, and Telomers andRelated Chemicals (AR-226). Limited toxicological, ecological, and related fate data now exist on [ 

### ,Jand some ofthe l. .]-derived polymers and otherrelated substances; see the PMN docket for these specific PMNs. There are limited pharmacokinetics studies on [ "J in the rat and the monkey. These studiesVlll indicate that the serum half-life is less than 24 hours in monkeys, which is considerably less than the half-life ofPFOA in monkeys and humans. The half-life ofPFOA in monkeys is 20.9 days infemale monkeys, 32.6 days in male monkeys, and 4.4 years inhumans. These data and assessments support the assessment ofreduced bioaccumulation of[ j relative to PFOA. In addition, EPA has reviewed a Combined Repeated-Dose Toxicity Study with Reproduction/Developmental Screening Test, (OECD 422) inrats for [ ] and the[·

- 1] conducted for another company and submittedto EPA. EPA's review ofthese subchronic and reproductive data on [
.

**~** and the [t 'J concluded that for
_ ] no reproductive effects were seen at any dose. Dose levels were 50, 150, and 450/300 mg/kg/day (450 was reduced to 300 in the study on day 4 because oftoxicity). However, systemic effects-primarily liver effects-were
seen. EPA's reviewplaces the No-Adverse Effect Level orNOAEL for [' , at 50 mg/kg/day. Forthe L j, the doses were 25, 75, and 225 mg/kg/day
. For systemic effects, there
was no NOAEL achieved with the Lowest-Adverse Effect level (LOAEL) at 25 mg/kg/day. For reproductive or developmental effects, the NOAEL is 75 mg/kg/day and LOAEL is 225 mg/kg/day. In 2006, another company submitted a 90-day oral repeated dose toxicity study (OECD 408) on 

### _J. Dose levels for this study were 0 (vehicle control), 10, 50, and 200 mg/kg/day and were based
on the previously described Combined Study (OECD 422). EPA's review sets the Lowest- Effect or Lowest-Adverse Effect Level (LOEL orLOAEL) at 10 mg/kg/day, based onthe body weight gain being lower in all treated groups ofmales. There was treatment-related toxicity inthe liver and the red blood cell system (anemia) in males at 200 mg/kg/day. There was also increased peroxisomal beta oxidation activity at this dose level. Hepatotoxicity and peroxisomal beta oxidation activity have also been seen in studies onPFOA. The significance ofthe finding ofa benign brain tumor (astrocytoma) in one male ratIX in the high dose group is not clear. 

### It is not the type oftumornormally associated with PFOA-type compounds, is not a rare tumor, and may be incidental. Abnormal histopathology was observed inthe testes (2 males) and epididymides (1 male) at 200 mg/kg/day and is a sign ofconcern for male reproductive toxicity. Furthertesting should investigate male reproductive effects. Fromthis study, the potential for immunotoxic effects is low. There have been some studies showing immunotoxic effects from PFOA. Any investigation ofimmunotoxic effects should await the corroborative testing nowbeing conductedby the EPA Office ofResearch and Development. There were no clinical signs of neurotoxicity and there were no treatment-related effects in the functional observationbattery or motor behavior in the study. Another 90-day study has been submitted to EPA on [ ]. EPA review ofthat study concluded that blood and liver effects were seen at the highest dose. This study had doses comparable with the other studies. Another 90-day study has been submitted to EPA on LJ ]. EPA review ofthat study concludedthat blood and liver effects were seen at the highest dose. This study had doses comparable with the other studies.A one-generationreproduction/developmental toxicity study in mice onthe ] was submitted to the Agency. In this study, pregnant mice were administered the test substance via gavage during gestation days 6-18. The NOAEL for maternal toxicity
was 175 mg/kg/day (the highest dose tested). Signs ofdevelopmental toxicity were observed at 175 mg/kg/day onthe postnatal day 1 and consisted ofincreases in the number ofstillbornpups and pup deaths, reductions inthe average pup body weight per litter with a pup with lenticular opacity. The NOAEL for developmental toxicty is 35 mg/kg/day.X A Chronic Toxicity, Carcinogenicity study was submitted in 2011. Doses were 2.5, 15, and 100 mg/kg/day for males and 5, 30, and 200 mg/kg/day for females. EPA review determined that no chronic toxicity orcarcinogenicity effects were seen inthe two lower doses. Due to limitations in the study no determination could be made for the highest doses. These and other datato date also indicate a different and less toxic profile for 

### I ], a potential environmental degradant ofthePMN substances, than for PFOA. Based on: 1) the persistence of[' ], 2) potential intermediate fate products, and 3) the likelihood thatthese substances may be used as major substitutes for some uses ofPFOA, EPAbelieves that information is needed on the toxicity of[ properties**of[~** ] and possibly other environmental degradants, and onthe fate and physical/chemical ] and 

## I ]-derived polymers in the environment. Additional relevant testing on analogous 

## L , ] substances will be developed by the National Toxicology Program orNTP in the so-called Perfluoro Class Study. Environmental Effects Summary: EPA has a low concern for the intact PMNs substances P-13- 646,647,648,649, and 678 based on data on [ potential concern based on [-

-- _]. ForP-13-679, EPA has a ]. EPA does not expect a significant environmental risk from any ofthe intact polymers. However, there is concern for possible environmental effects of the potential persistent degradation products ofthe PMN substances, including [ ], particularly in wild mammals and birds, and possibly to the reproductive capacity ofother species. The analog PFOA is persistent inthe environment and has a long bioretentiontime in various species. It has been detected in
a number ofwildlife species including marine mammals. It is toxic to mammalian and other species. The presence in the environment and the toxicological properties ofPFOA continue to be investigated. EPA believes development ofadditional data is warranted. The Company has agreed to conduct,Xl and the Consent Order requires the Company to conduct, a Fish Full Life Cycle study test and a Fish Reproduction study on a salt of[ ]. Exposure and Environmental Release Summary: Thermal and simulated incineration testing exists on some related polymers. This testing indicates that incomplete incinerationproducts are formed at lower incineration temperatures. EPA does not believe further thermal and simulated incineration testing is warranted for these polymers. Modified Zahn-Wellens biodegradationtests have been conducted on some related polymers. In addition, other fate tests have been conducted that showthat analogous polymers degrade. EPA believes that additional data onthe fate and transport ofthe PMN substances is warranted. EPA is requiring the Company to test the polymers in physical/chemical and environmental fate tests.

Physical/ChemicalPropertyTesting OPPTS or OECD Guideline Hydrolysis as a function ofpH OCSPP 835.2130, OECD Ill EnvironmentalFate Testing OPPTS or OECD Guideline Modified Semi-Continuous Activated OCSPP 835.5045, OCSPP 835. 3210, Sludge (SCAS) or Zahn-Wellens with Analysis fdDECD 302A or OCSPP 835.3200, degradation products OECD 302B Indirect Photolysis Screening Test OPPTS 835.5270 The fluorinated starting materials for the PMN substances will be imported. Forprocessing ofthe PMN substances into a polymer, the PMN substance will be processed at t]. Presently, all releases are [ ']. Environmental release to air via incineration is expected. The PMN substances are [· ] in solution and diuted/mixed down to [ ] in solution. These newchemicals are intended to be used in [ ] settings only. Use ofthe PMN substances: EPA expects that there is potential for dermal exposure to workers,xu but does not expect inhalation exposureto workers from processing or use at industrial sites. During use for P-13-646,647 678, EPA expects releases to air from incineration. During use for P-13-648,649, and 679 [ ], the substances may be released to water, incineration, or landfill. EPA estimates that the substances could be used at [
.· ··'] sites for [ ] days peryear.

V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine the potential for human health and environmental effects from exposure to the PMN substances and potential degradation products. EPA therefore concludes, pursuantto § 5(e)(1)(A)(i) ofTSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation ofthe human health and environmental effects ofthe PMN substances and potential degradation products. (b) In light ofthepotential risk ofhuman health and environmental effects posed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances, EPA has concluded, pursuant to§ 5(e)(1)(A)(ii)(l) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance maypresent an unreasonable risk ofinjury to human health and the environment. (c) In light ofthe estimated productionvolume of, and human exposure to, the PMN substances and potential degradationproducts, EPAhas further concluded, pursuantto § 5(e)(1)(A)(ii)(II) ofTSCA, that the PMN substances will be produced in substantial quantities and may reasonably be anticipated to enterthe environment in substantial quantities, and there may be significant (or substantial) humanX111 exposure to the substances and potential degradation products. VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND ENVIRONMENTAL EFFECTS
Triggered Testing. The Order prohibits the Company from exceeding specified production volumes unless the Company submits the information described inthe Testing section ofthis Order in accordance with the conditions specified in the Testing section. Pended Testing. The Order does not require submission ofthe following information at any specified time or production volume. However, the Order's restrictions onmanufacture, processing, distribution in commerce, use, and disposal ofthe PMN substances will remain in effect until the Order is modified or revoked by EPAbased on submission ofthe following or other relevant information. 1. Information on inhalation toxicology ifthe substances were to be sprayed by non-industrial, commercial or consumer applicants. This could include a 90-day inhalation study inrats with a 60-day holding period (OPPTS Guideline 870.3465 or OECD 413) or otherrelevant information. 2. The following physical/chemical properties and fate and transport tests (also discussed previously inthis preamble):

Physical/Chemical Property Testing OPPTS or OECD Guideline UV visible absorption OPPTS 830.7050 Environmental Fate Testing OPPTS or OECD Guideline Aerobic and Anaerobic transformations in OECD 308 Aquatic Sediment Systems Direct Photolysis in Water OPPTS 835.2210XIV Phototransformation Chemicals on Soil SurfacesOECD Jan. 2002 Draft Simulation test-Aerobic Sewage Treatment OECD 303A (Activated Sludge Units) Anaerobic biodegradability oforganic OECD 311 compounds in digested sludge Because ofthephysical/chemical properties ofthese substances, some modifications oftheprotocols may be necessary. These modifications will be agreed uponbyEPA andthe Company.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



## CONSENT ORDER

I. SCOPE OF APPLICABILITY AND EXEMPTIONS OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

(a) Scope. The requirements ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe following six chemical substances (the "PMN substances") in the United States by [ ] ("the Company"), except to the extent that those activities are exempted by paragraph (b). The six PMN substances subject to this Order are: 

## l

] P-13-646; I'
] P13-647;

.] P-13-648;

Internet Address (URL) ·http://www epa gov Recycled/Recyclable • Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper2

· :] P-13-649;

I P-13-678· and


### . , 

## J P-13-679.
(b) Exemptions. Manufacturing ofthe PMN substances is exempt from the requirements ofthis Order (except the requirements in the Record keeping and SuccessorLiability Upon Transfer OfConsent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documented by appropriate record keeping as required in the Record keeping section ofthis Order. (1) Export. Until the Companybegins commercial manufacture ofthe PMN substances for use in the United States, the requirements ofthis Order do not applyto manufacture, processing or distribution in commerce ofthe PMN substances solely for export in accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFRPart 707. However, once the Companybegins to manufacture the PMN substances for use inthe United States, no further activities bythe Company involving the PMN substances are exempt as "solely for export" even ifsome amount ofthe PMN substances are later exported. Atthat point, the requirements ofthis Order apply to all activities associated with the PMN substances while in the territory ofthe United States. Prior to leaving U.S. territory, eventhose quantities orbatches ofthe PMN substances that are destined for export are subject to terms ofthe Order, and counttowards any production volume test triggers in the Testing section ofthis Order. (2) Research & Development ("R&D"). The requirements of this Order do not apply to3 manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances in small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR720.36. The requirements ofthis Order also do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances when manufactured solely for noncommercial research and development per40 CFR 720.30(i) and TSCA §5(i). (3) Byproducts. The requirements ofthis Order do not apply to the PMN substances when they
are produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). (4) No Separate Commercial Purpose. The requirements ofthis Order do not applyto the PMN substances whenthey are manufactured, pursuant to any ofthe exemptions in 40 CFR 720.30(h), with no commercial purJ,ose separate from the substance, mixture, or article ofwhich they are a part. (5) Imported Articles. The requirements ofthis Order do not apply to the PMN substance when they are imported as part ofan "article" as defined at 40 CFR 720.3(c) and in compliance with 40 CFR 720.22(b)(1).
(c) Automatic Sunset. Ifthe Companyhas obtained for the PMN substances a TestMarket Exemption (TME) under TSCA §5(h)(l) and 40 CFR 720.38 or a LowVolume Exemption (LVE) or LowRelease and Exposure Exemption (LoREX) under TSCA §5(h)(4) and 40 CFR 723.50(c)(l) and (2) respectively, any such exemptionis automatically rendered null and void as ofthe effective date ofthis Consent Order.



### II. TERMS OFMANUFACTURE, PROCESSING, DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OFINFORMATION4 

### PROHIBITION The Company is prohibited from manufacturing the PMN substances inthe United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substances, and the completion ofEPA's review of, and regulatory actionbased on, that information, except in accordance with the conditions described in this Order.



### CHEMICAL SYNTHESIS AND COMPOSITION (a) Restriction. The Company shall not manufacture the PMN substances, P-13-646, 647,648, 649, 678, and 679 unless the 

## I ]starting material and the [ ] intermediate material is in compliance with and does not exceed the limits specified inTable 1 and Table 2. The Company shall analyze the products containing the PMN substances for the analytes specified in Table 3 upon initial commencement ofmanufacture, and for any ofthe PMN substances manufactured since the last required analysis at least annually analyze and report thereafter, until one year after the date ofthe lastjointmanufacture orprocessing ofa product that contains

**~** j products at the facility. The Company shall report annually to the Agency the levels ofimpurities [' 

## ·1 associated withthe PMN substances, P-13-646,647,648,649,678, and 679 manufactured bythe Company, as specified below. For routine analysis, the Company shall analyze the starting material, [, 

## 1for the following analytes shown in Table 1below: 

## l quarterly analyze the intermediate material, 

## l J, for the analyte [ below. The Company shall make its best effort to minimize[: .]. The Company will also
,] shown in Table 2,

### 5 ]and to seek to eliminate them. (b) Analysis and Reporting. The Company shall analyze representative samples ofproducts containing the PMN substances, P-13-646, 647, 648, 649, 678, and 679 manufactured bythe Companyto determine compliance with the requirements inparagraph (a). The Company shall also analyze the products containing the PMN substances at each manufacturing facility both (1) at the initial commencement of non-exempt manufacture ofthe PMN substances atthat facility, and (2) at least annually thereafter during every year in whichthe PMN substances are manufactured at that facility or imported. Ifany new facility ofmanufacture is added orifthe process ofmanufacture ofthe PMN substances are significantly altered, then the products containing the PMN substances or corresponding products containing the PMN substances must be analyzed at commencement, and annuallythereafter as set forth above. Ifthe PMN substances are imported, the Company shall obtain from the foreign manufacturer written documentation to certify that representative samples ofthe imported form ofthe PMN substance or corresponding products containing the PMN substance have been analyzed, consistent with the requirements ofthis paragraph (b), and determined to comply with the requirements ofparagraph (a). The Company shall report the above analysis to EPA at initial commencement ofmanufacture and again ifany new manufacturing facility is added orifthe process ofmanufacture ofthe PMN substance or any intermediate thereofis significantly altered. The Company shall continue to reportthese impurity levels to EPA annually, in a cycle complementaryto the [ 

## J. In addition to the reporting for the products containing the PMN substances themselves, the Company shall, for the 

# r· 1starting material, annually report (1) the average values and the range ofvalues, including outlying data, for the routine analysis for the analytes specified in Table 1 and (2) the results of the quarterly analyses for the analyte specified in Table 2.6 TABLE 1: TO BE ROUTINELY ANALYZED IN [ ] STARTING MATERIAL

Analyte CAS Number [i [ ] . J [ - - -- 

## - l 

## r ] 

## I ] [ ] TABLE2: TO BEANALYZED AT LEAST QUARTERLY IN[. ] MATERIAL 

# I**~naJyte** 

# I CASNumber

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### J
TABLE 3: Limit in [ 

### .J [' 

## l minimum 

## I ] (combined)

']INTERMEDIATE
] 

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# ~imit in [ ]

TO BE ROUTINELY ANALYZED AT START-UP AND AT LEAST ANNUALLY THEREAFTER IN THE PMN SUBSTANCES ORPRODUCTS CONTAINING THE PMN SUBSTANCES Limit inC

.

- Analyte CAS Number ] 

## l ] 

### [. ] 

## l [ ] 

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MANUFACTURING (a)(l) Prohibition. The Company shall not cause, encourage, or suggest the manufacture ofthePMN substances by any otherperson.7 (2) SunsetFollowing SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation ofa final significant new use rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA unless the Company is notified on or before that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, subparagraph (a)(l) shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNURhave beenresolved and the validity ofthe SNURaffirmed. (3) Notice ofSNUR. WhenEPApromulgates a final SNURfor the PMN substances and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each person whom it causes, encourages or suggests to manufacture or importthe PMN substances ofthe existence ofthe SNUR. (b) Contract Manufacturer. Notwithstanding paragraph (a), the Company may cause a "Contract Manufacturer" outside the Company to manufacture or import the PMN substances according to the following conditions: (1) The Contract Manufacturer must be under contractto the Company to manufacture the PMN substances solely for the Company. The contract must specify the identity ofthe PMN substances, the total quantities to be manufactured, and the basic technology to be used for manufacturing. (2) The Company shall obtain from each ContractManufacturer a signed copy ofthe Consent Order for Contract Manufacturer (to be attachedto this Order as Attachment C) and submit the copy to EPA along with the name, address, and telephone number ofa responsible official ofthe Contract Manufacturer. The Contract Manufacturer or Company must receive a fully executed copy ofthe Consent Order for Contract manufacturer from EPA before the Contract Manufacturer may begin manufacture or import. (3) Ifat any time, the Company learns that the Contract Manufacturer has failed to comply with8 any ofthe conditions specified in the Consent Order for Contract manufacturer, the Company shall

**im~ediately** cease to cause the Contract Manufacturer to manufacture ofthe PMN substances, unless the Contract Manufacturer is in compliance with a SNURfor the PMN substances, or unless the Company is able to document each ofthe following: (i) Thatthe Companyhas, within 5 working days, notified the Contract Manufacturerin writing that the Contract ManufaCturer has failed to comply with any ofthe conditions specified inthe Consent Order for Contract manufacturer. (ii) That, within 15 working days ofnotifying the Contract Manufacturer ofthe noncompliance, the Company received from the Contract Manufacturer, in writing, a statement ofassurance that the Contract Manufacturer is aware ofthe terms ofthe Consent Order for Contract Manufacturer and will comply withthose terms. (iii) If, after receiving a statement ofassurance from the Contract Manufacturer under subparagraph (B) ofthis Section, the Company has notice or knowledge that the ContractManufacturer has failed to comply with any ofthe conditions specified inthe Consent Order for Contract Manufacturer, the Company shall immediately cease to cause the Contract Manufacturerto manufacture the PMN substances, shall notify EPA ofthe failure to comply, and shall resume causing the Contract Manufacturerto manufacture or importthe PMN substances only upon written notification from the Agency.

TESTING (a) Section 8(e) Reporting. Reports ofinformation onthe PMN substances whichreasonably supports the conclusionthat the PMN substances present a substantial risk ofinjuryto health orthe environment, which is required to be reported under TSCA section 8(e) shall reference the appropriate PMN9 identificationnumberfor these substances and contain a statementthat the substance is subjectto this Consent Order. Additional informationregarding section 8(e) reporting requirements can be found at www.epa.gov/oppt/tsca8e.
(b) Notice ofStudy Scheduling. The Company shall notify, inwriting, the EPA Monitoring Assistance and MediaPrograms Division (2227A), Office ofEnforcement and Compliance Assurance, U.S. Environmental ProtectionAgency, 1200 PennsylvaniaAvenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study required to be performedpursuantto this Order, orwithin 15 days afterthe effective date ofthis Order, whichever is later: (1) The date whenthe study is scheduled to commence; (2) The name and address ofthe laboratory which will conduct the study; (3) The name and telephone number ofa person at the Company orthe laboratory whom EPA may contact regarding the study; and, (4) The appropriate PMN identificationnumber for each substance and a statementthat the substance is subjectto this Consent Order. The written notice shouldbe submitted to EPA as follows: Postal Mail Address U.S. Environmental Protection Agency GLP Section Chief- Pesticides, Water and Toxics Branch Monitoring Assistance and MediaPrograms Division (2227A) Office ofEnforcement and Compliance Assurance 1200 PennsylvaniaAvenue, N.W. Washington, DC 2046010 Courier Delivery Address U.S. Environmental Protection Agency GLP Section Chief- Pesticides, Water and Toxics Branch Monitoring Assistance and Media Programs Division (2227A) Office ofEnforcement and Compliance Assurance Room 7117B 1200 PennsylvaniaAvenue, N.W. Washington, DC 20004
(c) Good Laboratory Practice Standards and Test Protocols. Each studyperformed to address the risks identified in this Order mustbe conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduct any study that will use a modified version ofa published test guideline, the Company must submit written testprotocols to EPA for review (submission
( ofwritten test protocols is optional for tests that are to be conducted using unmodified publishedtest guidelines). Protocols must be submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. EPA will respond to the Companywithin 4 weeks ofreceiving the written protocols. EPA review ofa test protocol does not meanpre-acceptance oftest results.
(d) Triggered Testing Requirements. (i) The Company is prohibited from manufacturing or causing anotherperson (including a Contract Manufacturer) to manufacture ofthe six PMN substances P-13- 646, 647, 648, 649, 678, and 679 beyond the aggregate production volumes as specified below.Production Volume
] kgs

] kgs

Tier 3 [
. · · '] kgs 11

Modified SCAS for Insoluble and Volatile Chemicals,with analysis for degradation products or Zahn-Wellens inherent biodegradation test, w/analysis for degradation products Guidelines

OPPTS 835.5045, OECD 302A OPPTS 835.3200, OECD 302B Hydrolysis as a Function ofpH and temperature OECD 111, OPPTS 835.2130 Indirect Photolysis OPPTS 835.5270 FishLife-Cycle Toxicity OPPTS 850.1500 Fish Short-Term Reproduction Assay OECD 229,0PPTS 890.1350 (ii) The test substances for the Physical/Chemical and fate tests shall be the PMN substances P-13-649 and P-13-679. The test substance for the ecotoxicity fish studies shall be [ ]
. Chemical composition ofthe test substance shall be verified and a certificate ofanalysis submitted
.. (iii) Chemical composition ofthe test substance must be fully characterized. For polymers, characterization includes all informationrequired on pages 5 and 6 ofthe PMN form (i.e. EPA Form 7710-25), except that data onresiduals are only required for fluorinated substances. Although EPA understands that complete mass balance may not be achievable for the specified analytes, the Company shall attempt mass balance to the greatest extentpracticable. EPA prefers that the Company test the commercial substance. (iv) The Company must test for the following analytes in the Biodegradation Test OECD 302A, and OECD 302B) : 

### I12 (v) Because the environmental fate pathway for photolysis may be different than for biodegradation, the Company must test for the following analytes in the photolysis test: identify the major fluorinated fragments and volatiles including: [
_

]. (vi) Forthe hydrolysis test, the company must test for the analyte,

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPA the results ofany interimphase ofeach study; and (3) submit (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA priorto exceeding the applicable production limit. The final report and data must be submitted as a support document for the PMN substances, using the procedure set out in40 CFR 720.40. The final report shall contain the contents specified in40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the submission ofsuch information is mandatory. EPA will require the submission ofraw data such as slides and laboratory notebooks only ifEPA finds,
onthe basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannottake place inthe absence ofthese items.13 (f) Testing Waivers. The Company is notrequired to conduct a study specified in paragraph (d) ofthis Testing section ifnotified inwriting byEPA that it is unnecessary to conductthat study.
(g) Equivocal Data. IfEPAfinds that the data generated by a study are scientifically equivocal, the Companymay continue to manufacture and importthe PMN substances beyond the applicable production limit. To seek relieffrom any otherrestrictions ofthis Order, the Companymaymake a second attempt to obtainunequivocal databy reconducting the study under the conditions specified in paragraphs (b), (c), and (e)(l) and (2). The testingrequirements maybe modified, as necessary to permit
a reasoned evaluation oftherisks presented bythe PMN substances, only by mutual consent ofEPA and the Company.
(h) EPA Determination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report and data, the Companyreceives written notice that EPA finds thatthe data generated by a study
are scientifically invalid, the Company is prohibited from further manufacture ofthe PMN substances beyondthe applicable production limit. (2) The Companymay continue to manufacture and importthe PMN substances beyond the applicableproduction limit only ifso notified, in writing, by EPA inresponse to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) Ifthere is sufficienttime to reconductthe study in compliancewithparagraphs (b), (c), and (e) before exceedingthe production limit specified inparagraph (d), the Companymayrecondut the study. Ifthere is insufficienttime to recondut the study in compliance withparagraphs (b), (c), and (e) before exceeding the productionlimit specified in paragraph (d), the Company may exceed the14 production limit, but must otherwise comply with paragraphs (b), (c) and (e), and shall submit the report and data to EPA with a reasonable period oftime, all as specified by EPA in the notice described in subparagraph (h)(l). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data. (ii) The Company may, within 4 weeks ofreceiving from EPA the notice described in subparagraph (h)(l), submitto EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.
(i) Company Determination oflnvalid Data. (1) Except as described in subparagraph (i)(2), ifthe Companybecomes aware that circumstances clearlybeyond the control ofthe Company or laboratory will prevent, orhave prevented, development ofscientifically valid dataunderthe conditions specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import ofthe PMN substances beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearly beyond the control ofthe Company or laboratory will cause or have caused development ofscientifically invalid data. EPA will notifY the Company ofits response, in writing, within 4 weeks ofreceiving the Company's report. EPA's written response may either: (i) allowthe Companyto continue to manufacture and import the PMN substances beyond the applicable production limit, or (ii) require the Company to continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c), and (e)(l) and (2). Ifthere is sufficient time to conduct 

### otreconduct the study15 and submit the report and datato EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Companyto comply with subparagraph (e)(3), the Company may exceed the production limit and shall submitthe report and data in triplicate to EPA within a reasonable period of time, all as specified by EPA inthe notice described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data, as to whether the Company may continue to manufacture beyond the applicable production limit.


### G) Unreasonable Risk. (1) EPA may notifY the Company in writing that EPA finds thatthe data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substances will ormay present an unreasonable risk ofinjury to humanhealth orthe environment. EPA's notice may specifY that the Companyundertake certain actions concerning further testing, manufacture, processing, distribution, use and/or disposal ofthe PMN substances to mitigate exposures to or to better characterize the risks presented by the PMN substances. Within 2 weeks from receipt of such a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substances, unless either: (A) within 2 weeks from receipt ofthe notice, the Company complies with such requirements as EPA's notice specifies; or (B) within 4 weeks from receipt ofthenotice, the Company submits to EPA a written report refuting EPA's finding and/orthe appropriateness ofany additional requirements imposedby EPA. The Company may continue to manufacture, process, distribute, use and dispose ofthe PMN substances in accordance with the terms ofthis Orderpending EPA's response to the Company's written report. EPA16 will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks ofreceipt ofEPA's written response, the Company shall comply with any requirements imposed byEPA's response or cease all manufacture, processing, distribution, use and disposal ofthe PMN substances. ·
(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continue to obey all the terms ofthis Consent Order until otherwise notified in writing by EPA. The Company may, based upon submittedtest data or otherrelevant information, petitionEPAto modify or revoke provisions ofthis Consent Order pursuant to PartIV. ofthis Consent Order. RISK NOTIFICATION (a) Ifas a result ofthe test datarequired underthe terms ofthis Order, the Companybecomes aware that any ofthe PMN substances may present a risk ofinjury to human health orthe environment (or is so notified by EPA), the Company must incorporate this newinformation, and any information onmethods for protecting against such risk, into a Material Safety Data Sheet ("MSDS") for those PMN substances,
as described in40 CFR section 721.72(c), within 90 days from the time the Companybecomes aware of the newinformation. Ifthe PMN substances are not being manufactured, processed, or used inthe Company's workplace, the Company must add the new information to an MSDS before the PMN substances are reintroduced into the workplace.
(b) The Companymust ensure that any ContractManufacturers (as described in paragraph (b) ofthe Manufacturing section ofthis Order), persons who will receive the PMN substances from the Company,
or who have received the PMN substances from the Company within 5 years from the date the Company17 becomes aware ofthe new information described in paragraph (a) ofthis section, are provided an MSDS containing the information required under paragraph (a) within 90 days from the time the Company becomes aware ofthe newinformation.



### III. RECORDKEEPING (a) Records. The Company shall maintain the following records until 5 years afterthe date they are created and shall make them available for inspection and copying by EPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the PMN substances did infact qualify for any one
or more ofthe exemptions described in SectionI, Paragraph (b) ofthis Order. Suchrecords must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemptionbeing claimed by the Company. Any amounts or batches ofthe PMN substances eligible for the Export exemption in Section I, Paragraph (b)(l) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, copies ofthe export label and export notice to EPA, required by TSCA sections 12(a)(l)(B) and 12(b), respectively. Any amounts
or batches ofthe PMN substances eligible for the Research and Development exemptionin Section I, Paragraph (b)(2) ofthis Order, are exempt from all the requirements inthis Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records required by 40 CFR 720.78(b). For any amounts orbatches ofthe PMN substances claimed to be eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the Company shall keep**record~** demonstrating qualification for that exemption as well as the records specified inparagraphs (2) and (3) below, but is exemptfrom the other record keeping requirements inthis Record keeping section; (2) Records documenting compliance withthe Chemical Synthesis and Composition section of18 this Order, including the results from analyzing representative samples ofthese substances. (3) Records documenting the manufacture and importation volume ofthe PMN substances and the corresponding dates ofmanufacture and import; (4) Records documenting the names and addresses (including shipment destination address, if different) ofall persons outside the site ofmanufacture orimportto whomthe Company directly sells or transfers the PMN substances, the date ofeach sale ortransfer, and the quantity ofthe substance sold or transferred on such date; (5) Records documenting the address ofall sites ofmanufacture, import, processing, and use; (6) Copies ofmaterial safety data sheets required bythe RiskNotification section ofthis Order; (7) Copies ofany Transfer Documents and notices required bythe SuccessorLiability section of this Order, ifapplicable; and (8) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substances
are manufactured, imported, processed, orused.
(b) Applicability. The provisions ofthis Recordkeeping section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Company's customers.
(c) OMB Control Number. Underthe Paperwork Reduction Act and its regulations at 5 CPRPart 1320, particularly 5 CPR 1320.5(b), the Company is not required to respond to this "collection ofinformation" unless this Order displays a currently valid control number from the Office ofManagement and Budget (OMB), and EPA so informs the Company. The "collection ofinformation" required inthis TSCA §5(e) Consent Orders has been approved under currently valid OMB ControlNumber2070-0012.19 

### IV. REQUESTS FORPRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA may ocassionally conduct on-site compliance inspections ofCompany facilities and conveyances associated withthe PMN substances. To facilitate such inspections, EPApersonnel may contact the Company in advance to request informationpertinent to the scheduling and conduct ofsuch inspections. Such requests may be written or oral. The types ofinformation that EPA may request may include, but are not limitedto, the following: (i) Expected dates and times whenthe PMN substances will be inproduction within the subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to the PMN substances; (iii) Currentjob titles or categories for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to the PMN substances; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to the PMN substances; (v) Records required bythe Record keeping section ofthis Order; and/or (vi) Any other informationreasonably related to determining compliance with this Order or conducting an inspection for that purpose.
(b) Company's Response. The Company shall respond to suchrequests within a reasonable period of time, but in no event laterthan 30 days after receiving EPA's request. Whenrequested in writing by EPA, the Company's response shall be in writing. To the extent the information is knownto or reasonably ascertainable to the Company at the time ofthe request, the Company's response shall20 demonstrate a good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests.
(c) Confidential Business Information. Any Confidential Business Information ("CBI") thatthe Company submits to EPApursuantto paragraph (b) shall be protected in accordance with §14 ofTSCA and 40 CFRPart 2.

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by whichthe Company's rights and obligations under this Order may be transferred when the Companytransfers its interests inthe PMN substances, including the right to manufacture the PMN substances, to anotherperson outside the Company (the "Successor in Interest").
(b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Companyto the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN substances from the Company pursuantto 40 CFR 720.102, the Successor in Interest must submit new PMNs to EPA and comply fully with Section 5(a)(1) ofTSCA and 40 CFRpart 720 before commencing manufacture or import ofthe PMN substance. (2) AfterNOC. Ifthe transfer from the Companyto the Successor in Interest is effective after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and shall not be required to submit new PMNs to EPA.21 (c) Definitions. The following definitions apply to this SuccessorLiability section ofthe Order: (1) "Successor in Interest" means a person outside the Company who has acquired the Company's full interest in the rights to manufacture the PMN substances, including all ownership rights and legal liabilities, through a transfer document signed by the Company, as transferor, and the Successorin Interest, as transferee. The term excludes persons who acquire less than the full interest of the Company inthe PMN substances, such as a licensee who has acquired a limited license to the patent
or manufacturingrights associated withthe PMN substances. A Successor in Interest mustbe incorporated, licensed, ordoing business inthe United States in accordance with40 CFR720.22(3). (2) "TransferDocument" means the legal instrument(s) used to convey the interests inthe PMN substances, includingthe right to manufacture the PMN substances, from the Companyto the Successor in Interest.

(d) Notices. (1) Notice to Successor in Interest. On orbefore the effective date ofthe transfer, the Company shall provide to the Successorin Interest, by registered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days oftheeffective date ofthe transfer, the Company. shall, by registered mail, submit the fully executedNotice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 PennsylvaniaAvenue, N.W., Washington, D.C. 20460. (3) TransferDocument. Copies ofthe Transfer Documentmustbe maintained by the Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substances are manufactured22 or imported. Copies ofthe Transfer Documentmust also be made available for inspectionpursuant to Section 11 ofTSCA, must state the effective date and time oftransfer, and must containprovisions which expressly transfer liability for the PMN substances under the terms ofthis Order from the Companyto the Successor in Interest.
(e) Liability. (1) The Company shall be liable for compliance withthe requirements ofthis Orderuntil the effective date and time ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance withthe requirements ofthis Order effective as ofthe date and time oftransfer. (3) Nothing inthis section shall be construed to prohibitthe Agency from taking enforcement action againstthe Company afterthe effective date ofthe transfer for actions taken, or omissions made, during the time in whichthe Companymanufactured, processed, used, distributed in commerce, or disposed ofthe PMN substances pursuantto the terms ofthis Consent Order.
(f) Obligations to Submit Test Dataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Order requires the Companyto submittest data to EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMN substances manufactured and imported by the Company up to the date oftransfer shall counttowards the test trigger applicable to the Successor in Interest.



### VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Companymaypetition EPA at any time, based upon new information onthe health effects of, or human exposure to, the PMN substances, to modify orrevoke substantive provisions ofthis Order.23 The exposures and risks identified by EPA during its review ofthe PMN substances and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend or revoke this Order, EPA will consider all relevant information available at the timethe Agency makes that determination, including, where appropriate, any reassessment ofthe test data or other informationthat supports the findings inthis Order, an examination ofnewtest data orotherinformation oranalysis, and any otherrelevant information. EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will notpresent anunreasonable risk ofinjuryto health orthe environment and will notresult in significant or substantial human exposure or substantial environmental release inthe absence ofdata sufficientto permit a reasoned evaluation ofthe health or environmental effects ofthe PMN substances. In addition, the Companymaypetition EPA at any time to make other modifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent withthe structure and intent ofthis Order as issued.

### 24 VII. EFFECT OF CONSENT ORDER (a) Waiver. By consenting to the entry ofthis Order, the Company waives its rights to file objections to this Order pursuant to section S(e)(l)(C) offSCA, to receive service ofthis Order no later than 45 days before the end ofthe review period pursuant to section 5(e)(l )(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any other rights that the Company may have under TSCA.
(b) CBI Brackets. By signing this Order, the Company represents that it has carefully reviewed this document and hereby agrees that all information herein that is claimed as confidential by the Company (per section 14 offSCA, 40 CPR Part 720 Subpart E, and 40 CPR Part 2) is correctly identified within brackets and that any information that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within the brackets.



# ~J**~ ?)!)~**  D 

### e \ ' Chemical Control Division Office ofPollutionPrevention and Taxies

Date Name:

# L Title: [ Company: [·· 

## . .- . 1 

# J

# J - 

# lATTACHMENT A DEFINITIONS [Note: The attached Order may not contain some of the terms definedbelow.] "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed by the International Union ofPure and Applied Chemistry or the Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identify a chemical substance for the purpose ofconducting a hazard evaluation. "Company" means the person or persons subject to this Order. "Commercial use" means the use ofa chemical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Commonname" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other thanby its chemical name. "Consumer" means a private individual who uses a chemical substance or anyproduct containing the chemical substance in or around a permanent ortemporary household or residence, during recreation, or for any personal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold ormade available to consumers for their use in or around a permanent ortemporary household or residence, in or around a school, or in recreation. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, orthe like that contains a hazardous chemical. Forpurposes ofthis section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Contract Manufacturer" means a person, outside the Company, who is authorized to manufacture and importthe PMN substance under the conditions specified in PartII. ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or commonname used to identify a chemical substance or a mixture containing that substance. "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is underthe control of, and used only by, the person who transferred it from a labeled container and will only be used bythat person within the work shift in which it is transferred from the labelled container.2 "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health ofthe U.S. Department ofHealth and Human Services. "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, ormixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemical substance and the workplace mr may occur. "Non-industrial use" means use otherthan at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance (see TSCA s. 3(2)) described inthe Premanufacture notice submitted by the Companyrelevantto this Order.
"Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofprocessing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA-approvedprotocol or the Good Laboratory Practice Standards at 40 CFRPart 792 withoutprior or subsequent Agency approval thatprevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approvedprotocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk ofinjury to humanhealth orthe environment ofthe PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-term containment ofthe PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, ordisposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumeruse. "Workplace" means an establishment at one geographic location containing one ormore work areas.Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER

PMNNumber
1. Transfer ofManufacture Rights. Effective on the Company did sell or otherwise transfer to _, ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofa premanufacture notice ("PMN") and is governed by a Consent Order issued by the U.S. Environmental ProtectionAgency ("EPA") under the authority of§5(e) oftheToxic Substances Control Act (TSCA, 15 U.S.C. §2604(e)).
2. Assumption ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(3).
3. Confidential Business Information. The Successorin Interest hereby: reasserts,

_ relinquishes, or modifies all Confidential Business Information ("CBI") claims made by the Company, pursuantto Section 14 ofTSCA and 40 CFRpart 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer. Information which has beenpreviously disclosed to the public (e.g., a chemical identity that was not claimed as CBI by the original submitter) would not subsequentlybe eligible for confidential treatment underthis Notice ofTransfer.2 

### TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER

Company (Transferor)
Signature ofAuthorized Official 

### NOTICE OFTRANSFER (continued)
PMNNumber

Date
PrintedNarne ofAuthorized Official
Title ofAuthorized Official



### Successor in Interest
Signature ofAuthorized Official Date
PrintedName ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code3


### TOXIC SUBSTANCES CONTROLACT SECTION S(e) CONSENT ORDER NOTICE OFTRANSFER (continued)

Successor's Technical Contact
Address City, State, Zip Code
Phone